Kornimate/medical-research-clean huggingface dataset:
reveal the level of anxiety in patients with crohn's disease receiving adalimumab

Conditions: Severe Crohn's Disease; Anxiety

Summary: it has been shown that emotional health issues, such as state anxiety, are more prevalent in patients suffering from inflammatory bowel disease (ibd) compared to physically healthy subjects. such findings have to be taken into consideration when making an educated guess that psychological factors such as depression and anxiety in particular interact with the course of crohns disease. therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders. several studies have shown that treatment with tumor necrosis factor alpha (tnf-α) antibodies ameliorates the emotional/psychological status of patients, however the impact of adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (ibd) remains unclear. the primary objective of this study was to describe and evaluate changes in levels of anxiety assessed by validated patient questionnaires after 6 months of treatment with adalimumab.


Eligibility criteria:
inclusion criteria: * patients for whom adalimumab (humira) therapy is indicated and has been prescribed according to the product label and who meet the following criteria: * male and female patients aged 18 to 65 years suffering from severe active crohns disease, attending a routine medical visit. * able to complete questionnaires. * patients with status active severe crohns disease which required immunosuppressive treatment * patients must fulfil international and national guidelines for the use of a biologic therapies in crohns disease (chest x-ray and interferon gamma release assay (igra) or ppd (purified protein derivative)-skin test negative for tuberculosis). * patients have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. * patients who have been prescribed in line with the european summary of product characteristics (smpc) exclusion criteria: * the following patients will not be included in this observational study: * previous therapy with tnf-α blocker within the last 8 weeks * active central nervous system opportunistic infections or central nervous system malignancies. * history of cerebrovascular accident * abuse of illicit substances (such as psychoactive drugs) within the previous 3 months * change of medication-based treatment of generalized anxiety and panic disorder, psychiatric disorder * no informed consent * contraindication to adalimumab (humira) therapy according to the smpc * current or planned pregnancy * lactation according to smpc * planned change of site within the next 24 weeks.

Keywords: monoclonal anxiety antibodies adalimumab severe crohn's disease quality of life biological products
carbamazapine for inherited erythromelalgia patients with nav1.7 mutations

Conditions: Erythromelalgia

Summary: this research study is designed to investigate brain response using fmri scan, and behavioral responses, to treatment with the drug carbamazepine (cbz) in patients with the painful sodium channelopathy inherited erythromelalgia (iem). this study is designed to identify the central nervous system (cns) regions that are activated during ongoing or evoked pain attacks, and the altered cns response to cbz treatment. this will advance our understanding of how iem affects the brain. we also hope to validate a pharmacogenic approach to the study of iem by use of an fda approved drug. we hope, but cannot be sure, that subjects will directly benefit from this study.


Eligibility criteria:
inclusion criteria: * diagnosis/symptoms of em * specific nav1.7 sodium channel mutations (including s241t) exclusion criteria: * patients with no identified nav1.7 mutation
ache inhibitor and insulin

Conditions: Diabetes Mellitus

Summary: the investigator will examine the effect of a single dose of pyridostigmine, ache inhibitor on insulin secretion in healthy subjects. each subject will undergo an intravenous glucose tolerance test (ivgtt) where iv glucose will be administered and the glucose excursion and insulin secretion response will be evaluated by measuring insulin and glucose at different time points. the test will be carried out twice, once without and once with the administration of a single dose of pyridostigmine on two separate days. the investigator hypothesizes that inhibiting ache will potentiate insulin secretion.


Eligibility criteria:
inclusion criteria: * 18 years and older exclusion criteria: * bmi \>30 kg/m2 * fasting glucose \>100 * glycohemoglobin (hemoglobin a1c) 5.7% or more * history of asthma * use of medications that may interfere with glucose metabolism

Keywords: insulin secretion
metabolic response to chardonnay grape marc powder

Conditions: Dyslipidemia; Obesity

Summary: to determine if the addition of chardonnay grape marc (also called pomace) powder enriched with grape seed extract to the diet will result in reducing blood levels of cholesterol or triglycerides.

previous research on grape seed nutritional properties has predominantly been confined to grape seed extracts (gse) containing only soluble components. in animal models, gse has been shown to prevent increases in blood pressure, blood cholesterol, and insulin resistance. in humans, there have been improvements in blood pressure, however no significant effect on blood cholesterol levels. whole milled grape marc flours deliver more dietary complexity than seed extracts alone. in addition to the extractable and non-extractable polyphenols, flour offers dietary fiber, minerals, sterols and polyunsaturated fats. grape marc flour is currently used as a food ingredient that is incorporated into various baked goods. however, to obtain good control of the dose level, the product will be provided in capsule form for this study. for reference, a ½ cup of of a high polyphenol food such as blueberries, contains about 325 milligrams of polyphenols, thus even with the higher dose, participants will be receiving an amount of polyphenols that is less than ¼ cup of blueberries. the grape marc powder is prepared in a facility that is certified for producing food-grade products, and the nutritional composition and safety of the product will be thoroughly evaluated before we begin the study. the objective of the current study is to determine if this chardonnay grape marc powder enriched with grape seed extract supplementation has beneficial impacts on the human blood lipid profile and to correlate gut biome changes to human metabolism.

Eligibility criteria:
inclusion criteria: * bmi ≥ 25 and \< 40 kg/m2 * dyslipidemia as defined as (any one or all of the following values): * total cholesterol \> 190 mg/dl but \< 240 mg/dl * ldl-cholesterol \> 130 mg/dl but \< 160 mg/dl * hdl-cholesterol \< 40 mg/dl (men)/\<50 mg/dl (women) * fasting triglycerides \> 150 mg/dl but \< 300 mg/dl exclusion criteria: * renal, cardiovascular, gastrointestinal or hepatic disease, by medical history * history of a previous cardiovascular event * diagnosis of type 2 diabetes * pregnancy or lactation * use of tobacco * food sensitivities or allergies to the foods or components of foods provided in the standard meals including gluten, dairy, egg, soy, nuts, or seafood * use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months, and unwilling to discontinue use while participating in the study. * use of lipid-lowering, glucose-lowering, anti-hypertensive, or weight loss medications * use of antibiotics in the last three months.

Keywords: cholesterol triglyceride grape seed extract chardonnay marc powder polyphenol gut microbiome
electrophysiological-based estimation of cochlear implant fitting

Conditions: Cochlear Implants

Summary: the primary objective of this research is to evaluate the relationships between multiple data from cochlear implant (ci) adult users to and to estimate predictive models of their fitting parameters. in a group of patients, the electrically-evoked compound action potentials (ecap) will be collected intra-operatively and the correlation with demographic data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of ci), auditory performances and subjective measures used for implant fitting (hearing threshold and most comfortable level) will be calculated. in a second group of experienced users (more than 9months of use of their ci), ecap and electrically-evoked auditory brainstem response (eabr) will be collected after 9 months of ci experience and after 12 months or more of use. correlation analyzes with demographic data, performance and fitting parameters will be performed as well. statistical predictive models for both fitting at the activation or in experienced users should be developed according to the correlation analysis. the secondary objective is to evaluate the effects of simultaneous stimulation on hearing performances. simultaneous stimulations will be delivered in one ear (bimodal condition) in patients using an electro-acoustic stimulation device (eas) or in the two ears (binaural condition) for bilateral ci users. ecap, eabr and speech perception will be measured and compared in the different conditions.


Eligibility criteria:
inclusion criteria: * good general health status including no neuropsychological diseases affecting intellectual capacities * users of cochlear implant or electro-acoustic stimulation devices * normal otoscopy * no excessive sound exposure within 48h before the measure exclusion criteria: * for women, possibility of pregnancy (absence of effective contraception or confirmed menopause); * concomitant use of ototoxic or psychotropic treatment with anxiolytic and / or antipsychotic

Keywords: cochlear implant ecap eabr perceptual levels hearing performances
changes in ischemia and angina over 1 year among ischemia trial screen failures with no obstructive cad on coronary ct angiography

Conditions: Microvascular Angina; Angina Pectoris

Summary: serial assessment of angina status and ischemia on stress echo over one year among patients with moderate ischemia on stress imaging and non-obstructive cad on coronary ct angiography.

some people with chest pain are found to have open arteries on angiograms instead of blocked arteries and many, but not all, of these people have abnormal stress tests or other tests showing there is not enough blood flow to the heart. prior research has not made clear whether chest pain in such patients is due to heart disease or something else, in part because no one has found out whether chest pain and stress test results change in the same direction over time. this study will use two measurements of chest pain and two stress tests, one year apart, to find out if chest pain and abnormal stress tests are both caused by the same problem: not enough blood flow to the heart.the association between angina, ischemia and atherosclerosis severity at baseline will be examined, as will medication effects.

Eligibility criteria:
inclusion criteria: * enrolled but not randomized in ischemia trial * stress echocardiography used for enrollment\* * no obstructive cad on study coronary ct angiography (defined as no ≥50% stenosis in a major epicardial vessel) * ischemic symptoms (chest pain or other potential ischemic equivalent). * participant is willing to give written informed consent * age ≥ 21 years exclusion criteria: * inability to comply with protocol * prior pci or cabg
correlation between the amplitude of ankle dorsiflexion and occurrence of patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: the aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (adrom) measurement with weight bearing (wb) using an app on the smartphone (ihand) and to verify if there is correlation between the limitation of the adrom and the pfp.

the change in lower extremity movement pattern has been previously associated with severe knee disorders, including anterior cruciate ligament rupture, patellar tendinopathy, iliotibial band syndrome, and patellofemoral pain (pfp). the aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (adrom) measurement with weight bearing (wb) using an app on the smartphone (ihand) and to verify if there is correlation between the limitation of the adrom and the pfp.

Eligibility criteria:
inclusion criteria: * volunteers with a history of patelofemoral pain * presence of image (lesion) in cartilage tissue in nuclear magnetic resonance * knee dynamic valgus during the single leg squat test and step down test (clinical tests) exclusion criteria: * acute knee lesion * acute ankle lesion * surgical procedures before six months ago

Keywords: confiability ankle patellofemoral pain syndrome
efficiency of deep transcranial magnetic stimulation on patients with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this is a first feasibility study in order to test if deep transcranial magnetic stimulation (tms) treatment with high frequency (10hz) will improve the symptoms of patient mci (mild cognitive impairment). the hypothesis of the study is that high frequency treatment with deep tms will improve the daily functioning of patients who suffers from mci.


Eligibility criteria:
inclusion criteria: 1. men and women 50-80 years of age. 2. self reporting of the patient about memory deterioration, without any damage of daily lify functioning. 3. scored of one standard deviation below the average (according to standardization of age and years of schooling) in the memory index and mindstream test, without any major damage of other cognitive function) 4. score \>= 24 in mmse (mini mental state examination) test. 5. preserved cognitive and executive functioning, without dementia according to dsm -iv 6. lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis. 7. score of maximum 0.5 in the clinical dementia rating. in this test the score of the memory index will be 0.5 or 1, and not more then 1 point in two other index of this test. 8. capable and willing to provide informed consent. exclusion criteria: 1. any other axis i diagnosis as the primary diagnosis 2. any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication 3. history of non tolerance for tms treatment 4. diagnosis of severe personality disorder according to dsm-iv 5. current suicidal tendency 6. uncontrolled hypertension 7. history of epilepsy, seizure, or heat convulsion 8. history of epilepsy or seizure in first degree relatives 9. history of head injury or stroke 10. history of metal implants in the head (except dental fillings) 11. history of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps 12. history of drug or alcohol abuse 13. inadequate communication with examiner 14. participation in another clinical study, either concurrent with this trial or in the 3 months preceding it 15. inability to sign a consent form 16. women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse

Keywords: mild cognitive impairment, so stated deep transcranial magnetic stimulation
neoadjuvant and adjuvant sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage tanyn3m0 nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma (NPC)

Summary: to evaluate the efficacy and safety of neoadjuvant and adjuvant sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage tanyn3m0 nasopharyngeal carcinoma. the primary endpoint was 2-year failure-free survival (ffs). secondary endpoints included 2-year overall survival (os), distant failure-free survival (dffs), locoregional failure-free survival (lrffs), and adverse events.


Eligibility criteria:
inclusion criteria: 1. patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma; 2. age≥18 years; 3. staging tanyn3m0 (ajcc/uicc 9th edition) ; 4. eastern cooperative oncology group (ecog) performance status score of 0-1; 5. white blood cell≥3.5×10\^9/l,neutrophils≥1.5×10\^9/l, hemoglobin≥ 90 g/l, platelet (plt)≥ 100x10\^9/ l ; 6. transaminases≤2.5 times the upper limit of normal, total bilirubin \<1.5 times the upper limit of normal; 7. creatinine clearance ≥60 ml/min; 8. signed informed consent form. exclusion criteria: 1. hbsag positive and hbv dna \>1×103 copy/ml; 2. patients with positive hcv antibody test results; 3. active, known, or suspected autoimmune disease. participants with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, or hair loss, may be enrolled; 4. history of interstitial lung disease; 5. received systemic sex hormone or other immunosuppressive therapy with equivalent dose \> 10mg prednisone/day within 28 days before signing the informed consent. participants with a systemic sex hormone dose ≤10mg prednisone/day or inhaled/topical corticosteroids were enrolled; 6. have received or will receive live vaccine within 30 days before signing the informed consent; 7. pregnant or lactating women (pregnancy tests should be considered for sexually active, fertile women); 8. had other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer; 9. the subject is known to have a prior allergy to macromolecular protein preparations, or any of the components of sindillizumab; 10. human immunodeficiency virus (hiv) infection; 11. other conditions, as determined by the investigator, that may affect subjects' safety or compliance with the study include symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infection requiring systemic treatment, mental illness, or family and social factors.
non-invasive mri subclassification of heptocellular carcinoma - hepcast-study

Conditions: HCC; Hepatocellular Carcinoma; MRI

Summary: non-invasive mri subclassification of heptocellular carcinoma - hepcast-study

hepatocellular carcinomas (hccs) are a heterogeneous group of tumor subtypes with a different response behavior and prognosis. as a reaction, the world health organization (who) in its 5th version (updated in 2019) classifies no more two but eight subtypes, each with a different tumor biology and outcome. the new classification may serve as a key factor optimizing a more personalized therapeutic approach and therefore, especially diagnostic disciplines have to implement these new subtypes as soon as possible into their daily clinical routine algorithms. imaging does play a key role in this situation. newer and advanced mri techniques allow a precise tissue characterization. furthermore, with the help of latest generation hepatobiliary contrast agents like the usage of gd-eob (primovist) it is possible to quantify and measure the organ function and specific uptake behavior of focal liver lesions. another approach that hold promise for advancing the characterization of hccs heterogeneity is the use and development of artificial intelligence (ai)-based image postprocessing algorithms including radiomics analysis. to date there aren't any established imaging features correlating with any of the new who hcc-subtypes. the goal of our project is to identify imaging biomarkers correlating with the new hcc-subtypes, helping to classify them noninvasively. as a next step with the help of our collaborators we will facilitate a radiological-pathological reference database. in a third step and with the help of the data we curated we will try to identify morphologic imaging characteristics by the use of ai-based post-processing algorithms to classify the subtypes noninvasively and to predict / estimate patients individual therapy response and prognosis. the last challenge will be to implement these algorithms into daily clinical routine, we therefore have to identify interface dilemmas and present smart solutions to solve them. we are convinced that by implementing the updated who-criteria into clinical workflows current believes and guidelines in the diagnosis and therapy of hcc will change. mri hcc imaging with primovist will play a key role in this project. the results of our project may provide the knowledge to represent as a cornerstone in imaging and therapy assessment of hcc to improve a personalized therapy approach.

Eligibility criteria:
inclusion criteria: patients with hisopathologically confirmed hcc and mri in domo with the standard high-end mri primovist study protocol. exclusion criteria: unmet inclusion criteria. mri contraindications. patients declines.
psoriatic immune response to tildrakizumab

Conditions: Psoriasis Vulgaris

Summary: this study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the il23 blocker, tildrakizumab.

this is a one-arm, open-label study to examine the effect of tildrakizumab on cutaneous and blood immune cells of psoriatic patients. ten subjects with moderate to severe psoriasis will be enrolled. biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients with moderate-severe psoriasis or \> 5% body surface area affected. exclusion criteria: * taking systemic immunosuppressives in the last 4 weeks * pregnancy * severe immunodeficiency (either from genetic or infectious causes). * tuberculosis or other active serious infection * active systemic malignancy. * breast-feeding * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
long-term course of korean medicine treatment for lumbar disc herniation

Conditions: Low Back Pain; Sciatica; Intervertebral Disc Displacement

Summary: this observational study will assess the long-term course and effect of korean medicine treatment in lumbar intervertebral disc herniation patients who received integrative korean medicine treatment for 24 weeks as part of a previous clinical study.

this observational study will assess the long-term course and effect of korean medicine treatment in lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative korean medicine treatment for 24 weeks at jaseng hospital of korean medicine (gangnam main branch) as part of a previous clinical study which was conducted from november, 2006 to april, 2007, and give written informed consent to long-term follow-up assessment at 10 years.

Eligibility criteria:
inclusion criteria: * lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative korean medicine treatment for 24 weeks at jaseng hospital of korean medicine (gangnam main branch) as part of a previous clinical study which was conducted from november, 2006 to april, 2007 * patients who give voluntary written informed consent to long-term follow-up assessment (quantitative and qualitative questionnaires, and mri) at 10 years. exclusion criteria: * patients who cannot give voluntary written informed consent to this study or answer study questionnaires (e.g. severe psychological disorders) * patients participating in other clinical studies or otherwise deemed unsuitable by the researchers